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Proactive Care vs Education Program for Low Blood Sugar (PHT2 Trial)

Phase 3

Waitlist Available

Led By James Ralston, MD, MPH

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of severe hypoglycemia in the prior 12 months or impaired awareness of hypoglycemia

Diagnosed with type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 14 months

Awards & highlights

PHT2 Trial Summary

This trial will compare 2 methods to reduce severe hypoglycemia in people with type 2 diabetes: proactive care management & proactive care management plus an educational program. Results will be measured using surveys.

Who is the study for?

This trial is for adults over 18 with type 2 diabetes who are at risk of severe low blood sugar, currently prescribed insulin or identified as high-risk. Participants must be enrolled in KPWA, plan to stay for the next 6 months, and have had a severe hypoglycemia event or impaired awareness in the past year. Exclusions include those in nursing homes or hospice care, non-English speakers, those unable to consent or attend educational sessions, and individuals with certain medical conditions.Check my eligibility

What is being tested?

The study compares two methods to prevent severe low blood sugar in people with type 2 diabetes: proactive care management (nurse calls) alone versus adding 'my hypo compass' education program. The goal is to see if combining nurse outreach with this program is more effective than just nurse outreach by itself.See study design

What are the potential side effects?

Since this trial focuses on education and proactive management rather than medication changes, side effects may not be directly related but could include stress from participation or potential anxiety about managing hypoglycemia.

PHT2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had severe low blood sugar or didn't notice my low blood sugar in the last year.

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I have been diagnosed with type 2 diabetes.

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I am 18 years old or older.

PHT2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Self-reported severe hypoglycemia

PHT2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Proactive Care Management + my hypo compass education programExperimental Treatment2 Interventions

Group II: Proactive Care ManagementActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

539 Previous Clinical Trials

24,113,153 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

552 Previous Clinical Trials

29,997,599 Total Patients Enrolled

James Ralston, MD, MPHPrincipal InvestigatorKaiser Permanente Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the Proactive Care Management + my hypo compass education program pose any risks to those taking part?

"Based on available evidence, the safety of Proactive Care Management + my hypo compass education program was rated a 3. This is due to ample information substantiating its efficacy and multiple reports confirming its security."

Answered by AI

Is this experimental research endeavor currently seeking participants?

"According to information from clinicaltrials.gov, this medical trial is no longer recruiting patients after having been initially posted on January 26th 2022 and last updated on October 31st 2023. Fortunately, there are other 82 studies that are actively seeking participants at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)

2022. "Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04863872.

All > Hypoglycemia > Type 2 Diabetes